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Measurement of pre- and post-pneumococcal antibody levels after immunization with the 23-valent capsular polysaccharide pneumococcal vaccine (23vPPV) is indicative of a T-independent antibody response. The World Health Organisation ELISA is considered gold standard yet is labor-intensive and technically difficult to perform. Interpretation criteria defining an adequate response to 23vPPV remain controversial. The diagnostic Immunology Laboratory at The Royal Children's Hospital, Melbourne (RCH), performs an in-house multi-serotype automated ELISA. The primary objective of this study was to verify RCH interpretation criteria for the laboratory's automated ELISA. Forty pneumococcal conjugate vaccine (PCV)–naïve healthy adults aged 18 to 25 years and 22 PCV-primed healthy children aged 2 to 5 years were immunized with 23vPPV. A serum sample was collected immediately prior and 28 to 42 (± 7) days post immunization. Samples were analyzed on the Tecan Freedom Evo 200 ELISA with adequate response defined as post-immunization antibody level of 1.3 µg/mL or fourfold rise from baseline in ≥ 10/15 serotypes in adult participants and ≥ 4/8 serotypes in pediatric participants. Thirty-nine (97.5%) adults and 22 (100%) children achieved an adequate response to 23vPPV. In PCV-naïve adults, serotypes contained within the conjugate vaccines were less immunogenic, with 12 (30%) adults not achieving an adequate antibody response when only PCV serotypes were used for interpretation. Our diagnostic laboratory has verified the interpretation criteria used for an automated multi-serotype pneumococcal ELISA method. Clinical Trial Registration: ANZCTR registration number ACTRN12618000822280. [ABSTRACT FROM AUTHOR]

OBJECTIVE The aims of this study were to evaluate the effectiveness of a new automated continuous temperature monitoring system in detecting temperature excursions and describe the challenges of implementing such a system. DESIGN This study is an observational before-and-after audit comparing temperature excursions detected in the three months before and three months after the implementation of the new monitoring system at Eastern Health. Inclusion criteria consisted of all medicine and vaccine storage facilities monitored by the new automated temperature monitoring system. Four sites not connected to the new monitoring system were excluded. SETTING Eastern Health is a large tertiary metropolitan health service in Melbourne, Australia. It operates from 21 locations including seven teaching hospitals, with medicines and vaccines stored in 124 refrigerators, 6 freezers and 101 ambient room temperature storage locations. MAIN OUTCOME MEASURES An analysis of post-implementation data identified a potential association between refrigerator brands and temperature excursion rate. RESULTS There was a large increase in the number of temperature excursions detected post-implementation of the new automated monitoring system. 28,746, 24 and 8,966 temperature excursions were detected post-implementation compared to 344, 0 and 0 pre-implementation in refrigerators, freezers and ambient locations, respectively. The majority of temperature excursions detected in medicine and vaccine fridges were below +2°C (98.4%). One brand of refrigerators was linked to 27,231 (94.7%) excursions (p<0.001). CONCLUSIONS The new temperature monitoring system detects higher number of excursions which provides better visibility of performance, identifies areas of non-compliance, and guides and evaluates solutions. This study recommends that freezers and ambient storage locations are monitored as robustly as refrigerators, temperature monitoring devices are placed in close proximity to pharmaceuticals, and that healthcare organisations avoid purchasing unreliable medicine and vaccine refrigerators. Finally, this study suggests the development of a National Medicine Storage Guideline. [ABSTRACT FROM AUTHOR]